Trial Outcomes & Findings for BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases (NCT NCT03318549)

Last Updated: 2024-11-26

Results Overview

The study team will evaluate visual impairment through a composite score of visual functioning test, ranging from 0 to 100, with lower scores indicating worse visual impairment.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

4.5 years

Results posted on

2024-11-26

Participant Flow

No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Overall Study STARTED	14 28	89 178	12 24
Overall Study COMPLETED	9 18	63 126	6 12
Overall Study NOT COMPLETED	5 10	26 52	6 12

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Overall Study Withdrawal by Subject	5	19	2
Overall Study Physician Decision	0	4	1
Overall Study Lost to Follow-up	0	3	3

Baseline Characteristics

BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Control Group n=28 eyes Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group n=178 eyes Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group n=24 eyes Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Total n=230 eyes Total of all reporting groups
Age, Continuous	72.2 years STANDARD_DEVIATION 4.2 • n=5 Participants	67.7 years STANDARD_DEVIATION 9.7 • n=7 Participants	67.2 years STANDARD_DEVIATION 10.0 • n=5 Participants	—	—	—	—	68.2 years STANDARD_DEVIATION 9.3 • n=24 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	52 Participants n=7 Participants	4 Participants n=5 Participants	—	—	—	—	64 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	37 Participants n=7 Participants	8 Participants n=5 Participants	—	—	—	—	51 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	—	—	—	—	2 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	87 Participants n=7 Participants	12 Participants n=5 Participants	—	—	—	—	113 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	—	—	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	—	—	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	—	—	—	—	4 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	—	—	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	26 Participants n=7 Participants	4 Participants n=5 Participants	—	—	—	—	31 Participants n=24 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	58 Participants n=7 Participants	7 Participants n=5 Participants	—	—	—	—	78 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	—	—	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	—	—	—	—	2 Participants n=24 Participants

PRIMARY outcome

Timeframe: 4.5 years

Population: Two subjects with eyes with visual function tests with low reliability scores were excluded from the analysis. Monocular patients were included. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group.

The study team will evaluate visual impairment through a composite score of visual functioning test, ranging from 0 to 100, with lower scores indicating worse visual impairment.

Outcome measures

Outcome measures
Measure	Healthy Control Group n=28 eyes Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group n=170 eyes Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group n=20 eyes Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Visual Impairment Measured by Visual Functioning Test	80.6 score on a scale Standard Deviation 5.3	74.2 score on a scale Standard Deviation 13.0	81.1 score on a scale Standard Deviation 10.4	—	—	—	—

PRIMARY outcome

Timeframe: 4.5 years

The number of eyes showing progression (expressed in percentage) will be compared between the home-based Brain-computer interface (BCI) testing and standard clinical testing (standard automated perimetry, SAP)

Outcome measures

Outcome measures
Measure	Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group n=170 eyes Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group n=20 eyes Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Number of Eyes Showing Progression Progression by BCI only	—	33 eyes	7 eyes	—	—	—	—
Number of Eyes Showing Progression Progression by SAP only	—	26 eyes	0 eyes	—	—	—	—
Number of Eyes Showing Progression Progression by BCI and SAP	—	15 eyes	2 eyes	—	—	—	—
Number of Eyes Showing Progression No progression	—	96 eyes	11 eyes	—	—	—	—

PRIMARY outcome

Timeframe: 4.5 years

Population: Monocular patients were included. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group. Healthy Control Group Arm, participants in this Arm were not assessed for this endpoint, and therefore, no data were collected. Data collected for progressing eyes with a minimum of 1.5 years of follow-up.

The time to detect progression (years) will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).

Outcome measures

Outcome measures
Measure	Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group n=17 eyes Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group n=2 eyes Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Time to Detect Progression Measured in Years SAP	—	3.3 years Standard Deviation 1.3	2.9 years Standard Deviation 0.0	—	—	—	—
Time to Detect Progression Measured in Years BCI	—	2.7 years Standard Deviation 1.5	2.9 years Standard Deviation 0.0	—	—	—	—

SECONDARY outcome

Timeframe: 4.5 years

c-index will be calculated by the proportion of concordant pairs divided by the total number of possible evaluation pairs for progression. c-index is unitless.

Outcome measures

Outcome measures
Measure	Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group n=170 eyes Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group n=20 eyes Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Standard Automated Perimetry Will be Assessed by the C-index	—	.652 unitless	.667 unitless	—	—	—	—

SECONDARY outcome

Timeframe: 4.5 years

Population: Subjects with questionnaires with incomplete responses were excluded from the analysis. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group.

The scores on the NEI VFQ-25 subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Outcome measures

Outcome measures
Measure	Healthy Control Group n=13 Participants Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Glaucoma Group n=87 Participants Patients with diagnosed glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Suspicious of Having Glaucoma Group n=11 Participants Patients with suspicious of having glaucoma will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.	Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.	Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25	95.2 score on a scale Standard Deviation 6.1	91.3 score on a scale Standard Deviation 8.9	92.6 score on a scale Standard Deviation 5.1	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice Chair of Research

University of Miami

Phone: 305-326-6373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place